This invention relates generally to the field of anchoring or securement systems that fix or secure a medical device, a fitting fixture or a medical delivery line, to be referred to herein generically and representationally as a catheter or catheter assembly, to a patient. More particularly, the invention relates to such systems wherein the anchoring means is adhesively secured to the patient's skin and wherein the catheter is accessible for inspection or replacement without needing to remove the anchoring means from the patient's skin.
It is often necessary to provide a medical device with an attached conduit or tubular line system for the delivery of liquid into the circulatory system of a patient, a primary example of such a system being a catheter system. Rather than removing and reinserting a new hypodermic needle every time subsequent delivery of a liquid medication is needed, it is often more efficient and more comfortable for the patient to insert a catheter needle which is then left in place on the skin, connector means being utilized to attach delivery conduits. To prevent excessive movement of the needle, the needle is typically fixed to the patient using adhesive tape or the like. In addition, the flexible catheter tubes extending from the catheter main body or hub are also secured to the patient's skin with adhesive tape members. Such a fixation method is not optimum in that over time the securing adhesive members loosen such that the tubes and catheter main body do not remain securely affixed to the patient's skin, especially if the catheter assembly passes over the wrist or other body joint. To address this problem, it is known to actually suture a catheter main body, fitting or hub directly to the patient's skin. While providing a more secure long-term method of fixation, this solution is understandably not preferred by patients and can lead to other complications such as infection.
Adhesive-based anchoring devices or systems that better secure the catheter assembly without recourse to direct suturing have been developed and are especially useful in circumstances where there is a need to inspect, adjust or substitute the catheter. These anchoring devices typically comprise a relatively rigid and bulky plastic retainer or adaptor secured to an adhesively backed flexible wrap or bandage. A portion of the catheter tube or a catheter fitting or hub is received by the retainer and secured using a hinged cover, a press fit construction or similar means. While improving on the use of adhesive tape or suturing, these devices typically use relatively hard plastic members with relatively high profiles that can be uncomfortable to the patient. Other adhesive-based anchoring devices utilize padded bodies having relatively large recesses that expose a layer of adhesive, with the catheter main body or hub being held in place by a strap or cover member. The recesses, however, do not tightly restrict movement of the catheter bodies or hubs, such that over time the catheter loosens and must be re-affixed, and at least one portion of the catheter is compressed between two sheet members which no corresponding cavity or recess. Examples of such devices are shown in U.S. Pat. No. 6,827,706 to Tollini, U.S. Pat. No. 6,428,516 to Bierman, U.S. Pat. No. 5,413,562 to Swauger, U.S. Pat. No. D492,411 to Bierman, U.S. Pat. No. D470,936 to Bierman, U.S. Pat. No. D528,206 to Bierman, U.S. Pat. No. 6,837,875 to Bierman, U.S. Pat. No. 7,018,362 to Bierman et al., U.S. Pat. No. 4,250,880 to Gordon, U.S. Pat. No. 5,037,397 to Kalt et al., U.S. Pat. No. 3,834,380 to Boyd, U.S. Pat. No. 3,826,254 to Mellor, U.S. Pat. No. 4,129,128 to McFarlane, U.S. Pat. No. 5,192,274 to Bierman, U.S. Pat. No. 4,863,432 to Kvalo, U.S. Patent No. D503,977 to Bierman, U.S. Pat. No. 6,929,625 to Bierman, U.S. Pat. No. 6,837,875 to Bierman, U.S. Pat. No. 6,689,104 to Bierman, U.S. Pat. No. 6,979,320 to Bierman, U.S. Pat. No. 6,770,055 to Bierman, and U.S. Pat. No. 6,951,550 to Bierman.
It is an object of this invention to provide a catheter anchoring device and system that improves on known such systems by providing fixed attachment to the patient in a manner that is secure, low profile, comfortable, re-positionable and easy to inspect. It is a further object to provide such a device and system wherein the catheter, and in particular the catheter body member, fitting, connector or hub, is retained and restricted in all directions, particularly in all the horizontal directions and most particularly in the axial direction, by providing a recess or cavity to receive the catheter body member that is configured to correspond with the footprint configuration of the catheter body member.